By Rachana Pradhan, Kaiser Health News
President-elect Joe Biden has made COVID-19 a mainstay of his campaign, criticizing President Donald Trump’s leadership on everything from masks and campaign rallies to vaccines.
It was the easy part. Biden now has the urgent task of filling the top health care positions in his administration to help restore public confidence in the scientific institutions that Trump has repeatedly undermined and oversee the rollout of several vaccines against the disease. coronavirus to a skeptical public who fear being rushed by political opportunism. .
At the top of that list is a new commissioner from the Food and Drug Administration, an agency where Biden faces immense pressure to go faster than any other modern president as the pandemic rages on and COVID deaths are expected to increase. throughout the winter. This agency and its beleaguered staff will be counted on to give the green light to vaccines and therapies to fight the COVID pandemic.
Biden is expected to quickly announce his choices to lead the FDA and the Centers for Disease Control and Prevention, given their importance in informing the federal government’s COVID strategy, according to interviews with Biden advisers, former agency officials and Democrats aware of the transition team. internal function. But how long they will be able to start working after Biden’s January 20 inauguration is unclear.
The director of the CDC does not need confirmation from the Senate, thus avoiding an obstacle that could slow down this process. This is not the case with the commissioner of the FDA. As a result, even if Biden moves at breakneck speed to replace outgoing Commissioner Stephen Hahn, it could be weeks after Biden is in the White House before his pick can get down to business.
In the meantime, the FDA will face critical decisions regarding the vaccines needed to help the nation emerge from the pandemic. Biden will have to rely on a temporary FDA official to lead the 17,000-employee agency through one of the most difficult times in its history.
“Now is not the perfect time, of course,” said a former FDA official. “It’s a huge job.”
The power transition will come at one of the most publicized times for the FDA, as it examines several coronavirus vaccine candidates that may reach the public ahead of the inauguration. The Trump administration could oversee emergency authorizations for the initial vaccines from two pioneers, Pfizer and Moderna, which would be prioritized for healthcare workers and other groups at higher risk of serious complications from COVID. But vaccines from other companies that might be available to many more Americans – such as teachers, adults at low risk of serious health consequences if they become ill, and children – are almost certain to fall under the drug. FDA kicked off Biden for review because data on safety and efficacy is not expected until next year.
The FDA’s credibility in verifying the safety and benefits of COVID products has been in question for months, fueled by Hahn’s inaccurate claims about certain treatments for sick patients. In addition, infighting between local officials and those nominated by politics in the White House and the Department of Health and Human Services persisted even in the weeks leading up to the election, with HHS Secretary Alex Azar openly plotting the Hahn’s impeachment over disagreements over vaccination standards, Politico reported. in October.
In September, eight senior FDA officials who served in multiple jurisdictions made the extraordinary decision to publish an editorial in USA today stating that they would work with the agency’s leadership “to maintain the FDA’s unwavering commitment to ensuring that our decisions continue to be guided by the best science.”
“Protecting the independence of the FDA is essential if we are to do the best possible job of protecting public health and saving lives,” the officials wrote.
“Trust has eroded so significantly in these institutions that have undermined public trust, especially in vaccines,” a Biden adviser said of the FDA and CDC. “Leadership change is essential.”
Bringing new people into the federal government – where Biden is responsible for filling roughly 4,000 jobs filled by politically appointed people – is a huge slog in itself, let alone taking control of the US pandemic response. . Former President Barack Obama set the record for presidential appointments in the first 100 days, obtaining Senate confirmation for 69 appointees. The FDA commissioner was not one of them – Dr. Margaret Hamburg was not appointed until March 2009 and became commissioner in May. A similar timeline was held for Trump’s first FDA commissioner, Dr. Scott Gottlieb, who began in May 2017.
“It’s a tough time because you’re going to have a lot of people who have to fall into place,” said Max Stier, CEO of the Public Service Partnership, which advises presidential candidates and their teams to install new ones. administrations. “The track record has not been good in attracting people quickly.”
At the start of the Biden administration, it is expected that there will be a fair number of “acting” agency heads rather than Senate appointees, Stier said. Biden said he would trust government scientists on COVID vaccines. Former FDA officials have said in interviews that if there is an acting official in charge when a specific vaccine is under review, it shouldn’t make a difference as long-time scientists of the agency carry out the necessary scientific assessments.
Where it could make a difference is in the message and the accountability, not only to the new president, but to the public: the traditionally lower profile and temporary nature of an interim FDA commissioner is at odds. with the highly visible role the commissioner is supposed to play during a public health emergency, particularly in convincing people that vaccines are safe.
“An agency needs a face, and it is difficult for an ‘actor’ to be the face of the agency,” said a former senior agency official. “The job could be done, but communication is always better if there is an FDA commissioner who is willing to take responsibility.”
The messaging role has grown in importance since public confidence in a coronavirus vaccine has eroded dramatically. A September Pew Research Center poll found that only 51% of American adults would definitely or likely receive a vaccine to prevent COVID-19 if it was available, down 21 percentage points from May.
“Things can only get better,” said Michael Carome, director of the health research group at Public Citizen, a left-wing group that advocates for consumers’ interests. “I think an acting commissioner under a Biden administration will have a lot more confidence than the current commissioner of the FDA, who was bowed down by the White House.”
The FDA staffing policy indicates who should be the acting head of the agency in the absence of a permanent commissioner. The most recent version, from 2016, indicates that the position is delegated to the Deputy Commissioner for Food and Veterinary Medicine, a title that has since been recast as Deputy Commissioner for Food Policy and Response. The position is currently held by Frank Yiannas, a longtime food safety expert who joined the agency in 2018 following the retirement of Stephen Ostroff, a senior FDA scientist who served twice as Acting Commissioner. . The FDA did not respond to questions about whether it had a new staffing policy.
However, some administrations have ignored this policy. The Trump administration, for example, briefly installed senior HHS official Brett Giroir, a political member, as acting FDA commissioner, a move criticized by Democrats in Congress.
But crucial decisions await the new appointee.
The first officials would know if the COVID vaccines from Johnson & Johnson and AstraZeneca work in January or February, said Moncef Slaoui, the main scientific adviser to Operation Warp Speed, which funds several vaccines and treatments against the coronaviruses. Further efficacy trials won’t be completed until spring, he said in October.
The safety assessment will take even longer – clinical trials of Johnson & Johnson and AstraZeneca were already suspended earlier this year for safety reasons – and companies will not seek emergency clearance or approval from the FDA that once both parameters are known.
After four years of politicizing the science agency, an adviser to Biden said, the most important thing was to have “a reliable and credible voice to restore confidence in a vaccine.”
KHN (Kaiser Health News) is a non-profit news service covering health issues. This is an independent editorial program of KFF (Kaiser Family Foundation) which is not affiliated with Kaiser Permanente.
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